FDA 510(k)

Heart5R-110便携式X光机，Heart3R-110便携式X光机

K号: K220700 · 2022-05-04

申请人Yian Medical Technology (Haining) Co., Ltd.

决定日期2022-05-04

产品代码IZL

咨询委员会RA

决定实质等同

器械摘要

Heart5R-110 Portable X-Ray Machine, Heart3R-110 Portable X-ray Machine is the device name listed in this FDA 510(k) record. The listed applicant is Yian Medical Technology (Haining) Co., Ltd.. It received FDA 510(k) clearance on 2022-05-04 under 510(k) number K220700. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Heart5R-110 Portable X-Ray Machine, Heart3R-110 Portable X-ray Machine?

Heart5R-110 Portable X-Ray Machine, Heart3R-110 Portable X-ray Machine is a medical device that received FDA 510(k) clearance on 2022-05-04. The listed applicant is Yian Medical Technology (Haining) Co., Ltd.. The 510(k) number is K220700.

When did Heart5R-110 Portable X-Ray Machine, Heart3R-110 Portable X-ray Machine receive FDA 510(k) clearance?

Heart5R-110 Portable X-Ray Machine, Heart3R-110 Portable X-ray Machine received FDA 510(k) clearance on 2022-05-04, under 510(k) number K220700.

Who is the listed applicant for Heart5R-110 Portable X-Ray Machine, Heart3R-110 Portable X-ray Machine?

The FDA 510(k) record lists Yian Medical Technology (Haining) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Heart5R-110 Portable X-Ray Machine, Heart3R-110 Portable X-ray Machine?

The FDA product code for Heart5R-110 Portable X-Ray Machine, Heart3R-110 Portable X-ray Machine is IZL.

列明Yian Medical Technology (Haining) Co., Ltd.为申报人的其他记录

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